Journal of Clinical Epidemiology

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(2014)

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LETTER TO THE EDITOR Improving recruitment in pediatric clinical research: a strategy to consider In reply: We thank Benkouiten et al. [1] for their recent correspondence to the Editor on our multicenter survey that quantified refusal rates in pediatric clinical research and identified factors pertaining to studies and investigators that influenced the decision to participate [2]. We do agree that the presence of a dedicated clinical research assistant (CRA) to assist investigators in the recruitment of patients would be of great help in the context of research conducted by most experienced and motivated investigators such as, according to our results, recruiting pediatricians with teaching responsibilities. However, as shown by a previous qualitative study from our team [3], reluctance of investigators to enroll their patients in clinical research was, for a part of them, related to pediatricians’ personal concerns about the interest/burden ratio of the study or about anticipated refusals. In that case, the presence of a CRA will probably make no significant difference in recruitment rates. Also, participation of a CRA in the recruitment process raises legal and ethical questions. The Declaration of Helsinki [4] and the ICH Guidelines for Good Clinical Practice [5] state that a specifically trained person designated by the investigator can provide study information and obtain subject’s written informed consent. Nevertheless, it is a legal requirement in France and in other countries that these tasks be performed by a medical doctor (L. 1121-1, French Public Health Code). The mission of a CRA dedicated to recruitment should be clearly delineated with respect to the law. Training of CRAs should enable them to be familiar with not only the study protocol but also the specifics of the disease or the drug under evaluation, if applicable. This is essential to ensure that families will obtain complete and correct information before consenting. Benkouiten et al. suggest a very interesting and practical way to improve the participation rate in pediatric clinical research. We believe that such a way should be specifically evaluated in terms of effectiveness and in terms of ethics.

Conflict of interest: The authors declare that they have no conflict of interest. 0895-4356/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved.

Florentia Kaguelidou* AP-HP, H^ opital Robert Debre Unite de Pharmacologie Pediatrique et Pharmacogenetique INSERM CIC9202, 48 boulevard Serurier 75019, Paris, France Universite Paris Diderot Sorbonne Paris Cite 75013, Paris, France

Philippe Amiel Institut de cancerologie Gustave-Roussy Unite de recherche en sciences humaines et sociales 114 rue Edouard Vaillant 94800, Villejuif, France

Claude Gaultier AP-HP, H^ opital Robert Debre INSERM CIE5, 48 boulevard Serurier 75019, Paris, France Universite Paris Diderot Sorbonne Paris Cite 75013, Paris, France

Corinne Alberti AP-HP, H^ opital Robert Debre Unite d’Epidemiologie INSERM CIE5, 48 boulevard Serurier 75019, Paris, France Universite Paris Diderot Sorbonne Paris Cite 75013, Paris, France *Corresponding author. Tel.: þ33-1-40034142; fax: þ33-1-40-03-24-24. E-mail address: [email protected]

References [1] Benkouiten S, Minodier P, Raoult D, Brouqui P. Obtaining informed consent in pediatric clinical trials. J Clin Epidemiol [in press]. [2] Kaguelidou F, Amiel P, Blachier A, Iliescu C, Roze JC, Tsimaratos M, et al. Recruitment in pediatric clinical research was influenced by study characteristics and pediatricians’ perceptions: a multicenter survey. J Clin Epidemiol 2013;66:1151e7. [3] Amiel P, Moreau D, Vincent-Genod C, Alberti C, Hankard R, Ravaud P, et al. Noninvitation of eligible individuals to participate in pediatric studies: a qualitative study. Arch Pediatr Adolesc Med 2007;161(5):446e50. [4] Available at http://www.wma.net/en/30publications/10policies/b3/. Assessed January 21, 2014. [5] Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_ Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf. Assessed January 21, 2014. http://dx.doi.org/10.1016/j.jclinepi.2014.02.003

Improving recruitment in pediatric clinical research: a strategy to consider.

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